ENGLEWOOD, Colo., April 20,
2022 /PRNewswire/ -- Ampio Pharmaceuticals,
Inc. (NYSE American: AMPE), a biopharmaceutical company
focused on the advancement of immunomodulatory therapies for the
treatment of pain resulting from osteoarthritis in the knee and
potentially other articular joints, today announced the
receipt of written responses from the United States Food and Drug
Administration (FDA) pursuant to a Type C meeting request submitted
by the Company earlier in the year regarding the AP-013 trial
results.
As previously disclosed, the Company submitted its Type C
meeting request to gain clarity from the FDA regarding the
acceptability of the proposed modified intent-to-treat (mITT)
population as the primary analysis population for evaluating
efficacy in the AP-013 trial, and the acceptability of AP-013 as a
second pivotal trial to support a biologics license application
(BLA) for Ampion.
FDA responded that it did not agree with the Company's proposed
change from the ITT population to the mITT population for the
primary endpoint analysis, that mITT is a substantive and material
change to the Protocol and Statistical Analysis Plan that is not in
accordance with the Special Protocol Assessment agreement, and that
despite the COVID related impact on patients and trial centers, the
Company should have sought FDA's agreement on these changes prior
to analyzing and unblinding the data. FDA further stated that
it did not agree that AP-013 could serve as a second pivotal trial
for Ampion based on both the change in the analysis population and
the analysis of pain only instead of the original prespecified
co-primary endpoints.
"We are very disappointed in FDA's answer. Ampion has been in
development for several years, and many shareholders have remained
loyal to the company throughout the ups and downs of that
development history. Severe osteoarthritis of the knee is an unmet
medical need that affects nearly 17 million people in the United States, and we continue to believe
that Ampion is a drug which can provide a safe and efficacious
treatment for many of those patients. However, given the points in
FDA's answer, it will be very difficult to salvage AP-013 itself as
a pivotal trial. Nonetheless, we and our regulatory experts believe
there may be ways to do that, and we will follow-up with the FDA in
the near term to discuss those options," said Mike Martino Chief Executive Officer and
Chairman of Ampio. "However, I want to be clear. At this point, I
believe the best path forward for Ampio and Ampion is likely
conducting a new Phase 3 trial. This management team has learned a
great deal from conducting and analyzing the prior trials,
including AP-013, and believe we are positioned to design and
execute a trial that can lead to BLA approval."
About Ampio Pharmaceuticals
Ampio Pharmaceuticals,
Inc. is a biopharmaceutical company focused on the advancement of
immunomodulatory therapies for the treatment of pain resulting from
osteoarthritis in the knee and potentially other articular joints.
Ampio's lead drug, Ampion™, is backed by an extensive patent
portfolio with intellectual property protection extending through
2037 and may be eligible for 12-year FDA market exclusivity upon
approval as a novel biologic under the Biologics Price Competition
and Innovation Act (BPCIA).
Forward Looking Statements
Ampio's statements in this
press release that are not historical fact, and including, but not
limited to, statements that relate to future plans or events or are
conditional in nature, are forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements can be identified by the use of words
such as "believe,"" may", "will", "should", "forecast", "could",
"expect", "suggest", "plan," "believe", "estimate", "continue",
"anticipate"," and "intend", "ongoing", "opportunity", "potential",
"predicts", "seek", "plan,", or similar expressions words. These
forward-looking statements include statements regarding Ampio's
expectations with respect to Ampion and its classification, as
well as those associated with regulatory approvals and other FDA
decisions, clinical trials (and FDA's decisions regarding such
trials), results of safety profiles, and decisions and changes in
business conditions and similar events and the likelihood and
timing of Ampion's approval as a novel biologic under the
BPCIA, all of which are inherently subject to various risks
and uncertainties. The risks and uncertainties involved include
those detailed from time to time in Ampio's filings with the
Securities and Exchange Commission, including without limitation,
under Ampio's Annual Report on Form 10-K and other documents filed
with the Securities and Exchange Commission. Such risks include,
but are not limited to: our ability to fund our operations,
including our ability to access funding through our "at-the-market"
equity offering or through other equity or debt offerings; our
ability to retain key employees, consultants, and advisors and to
attract, retain and motivate qualified personnel; the progress and
results of clinical trials for Ampion and additional costs or
delays associated such trials, including with respect to AP-013;
the significant competition in the search for a successful
treatment for the novel Coronavirus Disease 2019 ("COVID-19"); our
ability to enroll hospitalized patients in our Phase 1 and 2 trials
of Ampion for the treatment of COVID-19 given the unplanned
variability of the virus, vaccine rates and mutations in the virus
in certain geographies; our ability to receive regulatory approval
for and sell the products that we are developing for the treatment
of COVID-19; our reliance on third parties to conduct our clinical
trials resulting in costs or delays that prevent us from
successfully commercializing Ampion; competition for patients in
conducting clinical trials, delaying product development and
straining our limited financial resources; the risk and costs
associated with our decision to suspend enrollment in the Phase 3
clinical trial for treatment of severe Osteoarthritis of the Knee
due to considerations relating to the COVID-19 pandemic, and the
risk that generated by that clinical trial was adversely impacted
by the COVID-19 pandemic; our ability to navigate the regulatory
approval process in the U.S. and other countries, and our success
in obtaining required regulatory approvals for Ampion on a timely
basis; commercial developments for products that compete with
Ampion; the actual and perceived effectiveness of Ampion, and how
Ampion compares to competitive products; adverse effects and the
unpredictable nature of the ongoing COVID-19 pandemic; adverse
developments in our research and development activities; potential
liability if any of our product candidates cause illness, injury or
death, or adverse publicity from any such events; our ability to
operate our business efficiently, manage capital expenditures and
costs (including general and administrative expenses) and obtain
financing when required; and our expectations with respect to
future licensing, partnering or other strategic activities. Ampio
undertakes no obligation to revise or update these forward-looking
statements, whether as a result of new information, future events
or otherwise.
Investor and Media Contacts:
Russo Partners
Tony Russo or Nic Johnson
info@ampiopharma.com
tony.russo@russopartnersllc.com
nic.johnson@russopartnersllc.com
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SOURCE Ampio Pharmaceuticals, Inc.